The present invention relates to a transfer port system to allow material transfer between two sterile environments in which the two sterile environments dock with one another during the material transfer. More particularly, the present invention relates to such a transfer port system in which doors provided for access to the two sterile environments are sealed by gaskets. Even more particularly, the present invention relates to a transfer port system in which gasket surfaces are heated to maintain sterile conditions during the material transfer between the sterile environments.
The use of sterile manufacturing environments has become increasing more important in many industrial processes. In this regard, the electronic and pharmaceutical industries have a particularly low tolerance for inorganic and organic contaminants. An example of processing that must be conducted in aseptic conditions concerns the preparation of medicants, solutions, and suspensions within the pharmaceutical industry by freeze drying. In accordance with such production, the product is loaded into vials under sterile conditions and is then transported in an transporter isolator to a freeze dryer. The transporter isolator is a sterile vehicle for the transport of vials and docks at the end of its journey with the freeze dryer for the transfer of vials onto the shelves of the freeze dryer. After the docking of the transporter isolator and the freeze drier and the transfer of the vials, the product is freeze dried and the vials are stoppered within the freeze drier. Between freeze drying operations, the freeze dryer can be sterilized with steam, hydrogen peroxide vapor solutions and the like so that its sterility is maintained.
As can be appreciated, during the transfer of vials into the freeze dryer from the transporter isolator, a sterile interface must be maintained between the transporter isolator and the freezer dryer chamber. The same problem exists in any transfer port system in which material transfer is to be accomplished between two sterile environments. The difficulty in the maintenance of the sterile interface is that components of the transfer port system have been exposed to unsterile ambient conditions prior to linkage or docking of the two sterile environments. This problem is compounded by imperfections in the mating of components of the transfer port system. In order to maintain sterility at the interface, heat is applied to the components that have been exposed to the unsterile environment. Such sterilization is not without problems due to the thermal mass of the components of the transfer port system and the attendant required heating time to attain an assurance of a sterile condition.
As will be discussed, the present invention provides a transfer port system that is designed such that its components can be rapidly heated in order to maintain the necessary sterile interface between sterile environments during material transfer. Additionally, the transfer port system is designed to accommodate slight misalignments between its components.